ANTI-INFLAMMATORY ACTIVITY AND IRRITATION TEST OF TOPICAL DOSAGE FORMS OF CLOVE LEAF ESSENTIAL OIL (SYZYGIUM AROMATICUM) IN ANIMALS

IKA BUANA JANUARTI; FADZIL LATIFAH; RICKY FIRMANSYAH; AULYA D. PERTIWI; NIKEN AGUSTYA; HESTI WIDYAWATI

doi:10.22159/ijap.2024v16s5.52483

Authors

IKA BUANA JANUARTI Program Study of Pharmacy, Faculty of Pharmacy, Universitas Islam Sultan Agung, Jl. Raya Kaligawe KM.4, Semarang-50112, Indonesia https://orcid.org/0000-0003-2257-2459
FADZIL LATIFAH Program Study of Pharmacy, Faculty of Pharmacy, Universitas Islam Sultan Agung, Jl. Raya Kaligawe KM.4, Semarang-50112, Indonesia
RICKY FIRMANSYAH Program Study of Pharmacy, Faculty of Pharmacy, Universitas Islam Sultan Agung, Jl. Raya Kaligawe KM.4, Semarang-50112, Indonesia
AULYA D. PERTIWI Program Study of Pharmacy, Faculty of Pharmacy, Universitas Islam Sultan Agung, Jl. Raya Kaligawe KM.4, Semarang-50112, Indonesia
NIKEN AGUSTYA Program Study of Pharmacy, Faculty of Pharmacy, Universitas Islam Sultan Agung, Jl. Raya Kaligawe KM.4, Semarang-50112, Indonesia
HESTI WIDYAWATI Program Study of Pharmacy, Faculty of Pharmacy, Universitas Islam Sultan Agung, Jl. Raya Kaligawe KM.4, Semarang-50112, Indonesia

DOI:

https://doi.org/10.22159/ijap.2024v16s5.52483

Keywords:

Eugenol, Essential oils, Anti-inflammatory, Irritation test, Clove leaf, Emulgel, Stick balm, Balsam, Massage oil

Abstract

Objective: Clove leaves (Syzygium aromaticum) contain compounds, namely eugenol, alpha-humulene, beta-caryophyllene, and caryophyllene oxide with the main compound eugenol, which has anti-inflammatory activity. One of dosage form to treat inflammation on the skin is a topical dosage form because it is quickly absorbed into the skin. This study aimed to formulate Clove Leaf Essential Oil (CLEO) and evaluate the physical properties, anti-inflammatory activity, and irritation effects of various topical dosage forms (emulgel, balsam, massage oil, and stick balm).

Methods: Research design was a pre-posttest control group. Essential oils were obtained using the steam distillation method. The four different concentrations of CLEO topical dosage form (emulgel, balsam, massage oil, and stick balm) are 5% and 10%. Then, test are conducted on the physical qualities (organoleptic, pH, displaced volume, spreadability, sticking power, moisture content and viscosity). Anti-inflammatory activity using the carrageenan-induced paw edema method in Wistar rats was divided into four groups are dosage form CLEO concentrations of 5% and 10%, base preparation, and positive control. Anti-inflammatory activity results were analyzed with Post-hoc statistical analysis with a 95% confidence level. The irritation method was used to measure the Primary Irritation Index (PII) followed procedure by Indonesian Food and Drug Authority about Guidelines for in vivo Preclinical Toxicity Testing.

Results: All these dosage forms met the physical requirements. Anti-inflammatory activity will rise as result of increasing the CLEO content in the formulae. All these dosage forms did not cause irritation in animal.

Conclusion: Among the four formulations, balsam CLEO 10% showed maximum inhibitory oedema (94.05%), at the end of 360 min followed by balsam CLEO 5%, emulgel CLEO 10%, stick balm CLEO 10% and massage oil CLEO 10%.

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